Daré Bioscience, Inc. (NASDAQ:DARE) Q4 2022 Earnings Call Transcript

So there is, therefore, interest, right and thinking about how great it would be for these women to have an option that can deliver effectiveness in a nonoral route, in a vaginal route administration that, again, is — has that potential benefit. So that’s why we’re looking forward to and excited about it and excited to have a possibility of giving women an option that’s very different from anything that is available to them today. And again, it’s more in mind in delivering something more resident to where she’s having the problem.

Operator: Your final question comes from the line of Kemp Dolliver from Brookline Capital Markets.

Kemp Dolliver: I’m going to ask 2, hopefully, brief questions. First, how are you thinking about 2023 spending levels relative to 2022?

Sabrina Johnson: Yes, great question. As you know, we typically don’t give a lot of like forward-looking guidance around our spend. And we have been fairly consistent historically with how we spend. But the important thing to keep in mind is that the spending, you heard G&A is around last year is $11 million, right? What we spend is primarily associated with the development programs, right? That’s the bulk of where we use our capital. And the majority of the expenses, again, not surprising, is with our later-stage programs, right? And so as we think about the first half of this year, you’re right, our research and development expenses are going to be primarily associated with the completion of the Sildenafil study and manufacturing activities around the Ovaprene study, right, to prepare for Ovaprene.

So we’re always closely monitoring our cash and our resources and thinking about the timing of incurring expenses versus our opportunities to bring in capital, right? We also always we’re a development stage company. We’re always bringing in capital in different ways and means. So as we think about this year, we obviously — we have some important activities around Sildenafil and Ovaprene primarily that we’re very focused on in the first half of this year but we obviously have expenses, right, that yes, we can control but that we’re going to incur as we think about progressing the other programs in the later part of the year that we talked about. But that’s where the variability is, the G&A has been very fixed over time, pretty consistent. It’s really around where we spend on development.

Kemp Dolliver: Super. And my second question relates to the Sildenafil study. And the question — so the questionnaire and the amount of data you need to analyze. And so how many question answer — questions or answers or in this question depending on what’s the better way to think about it? And then how long do you think you’ll need to analyze the data to put together the Phase III design?

Sabrina Johnson: Yes, that’s a fantastic question. So first of all, in terms of just the primary and secondary, it’s a very reasonable number, right? It’s less than 10, kind of individual questions and domains. The bigger piece is related to the exploratory. This study was designed to ask even sometimes the same question in different ways. So we have electronic diary data that is post sexual event over the course of the week, over the course of the month, we have other data that’s collected only on a monthly basis, right? So there is absolutely a lot of information. Having said that, we are very motivated to go as quickly as we possibly can to pull all these data together and get it to the FDA this year. That is a clear priority for us.